The present invention relates to a urinary incontinence device and a method of using the same. More specifically, this invention relates to a cost-effective C-shaped device for alleviating female urinary incontinence, particularly during episodes of increased intra-abdominal pressure.
The primary etiological factor producing genuine stress urinary incontinence is the incomplete transmission of abdominal pressure to the proximal urethra due to displacement from its intra-abdominal position. Some women, especially women who have given birth to one or more children, and older women, can experience incidences of involuntary urine loss due to stress urinary incontinence or combined stress and urge incontinence. A sneeze or cough increases the intra-abdominal pressure, which in turn increases the pressure on a person""s bladder causing the involuntary release of urine. The frequency and severity of such urine loss can increase as the muscles and tissues near the urethro-vaginal myofascial area grow weaker. It has also been recognized that the urinary sphincter muscle, which is located at the upper end of the urethra, adjacent to the bladder, works well at sealing off the passing of urine from the bladder to the urethra when it has a round or circular cross-sectional configuration.
Support of the proximal urethra elevates it above the pelvic floor and subjects it to increases in intra-abdominal pressure, thus allowing compression and maintenance of continence. When this passageway becomes distorted into a cross-sectional configuration having more of an elliptical or oval appearance, however, the sphincter muscle can not close properly. Therefore, the tendency for involuntary urine loss increases. One must remember that the urethra and vagina are not separate structures. Because of their common derivation from the urogenital sinus, they are fused in the distal two-thirds of the urethra. In this region they are bound together by the endopelvic connective tissue so that the support of the urethra depends not only on the attachments of the urethra itself to adjacent structures but also on the connection of the vagina and periurethral tissues to the pelvic wall.
As the world""s female population ages, there is an ever-increasing need for a non-surgical method or measure to reduce the involuntary urine loss commonly associated with stress urinary incontinence. Although there are specialized products available for this purpose, most can only be purchased with a prescription and they need to be properly sized, physically inserted and/or adjusted by a medical doctor for them to correctly perform.
In view of the lack of non-prescription, commercially available devices, there is a need for a urinary incontinence device that the consumer can purchase and that is uncomplicated and user friendly. Furthermore, there is a need for a urinary incontinence device that is easy for a woman to insert into and remove from their body that is more comfortable to wear and to provide psychological and realistic assurance that it is capable of properly performing over an extended period of time.
The present invention relates to an intra-vaginal urinary incontinence device that includes a flexible base portion that connects a proximal portion of a first leg and a proximal portion of a second leg to form a generally xe2x80x9cC-shapedxe2x80x9d configuration. The device also includes a member selected from the group consisting of an insertion member, a removal member, or both. The device may be formed of a resilient material so that the distal portion of the legs can be moved toward each other to aid in the insertion of the device into the vaginal canal.
In addition, the base of the device may bias the legs outwardly or in a direction away from each other so that, in use, the device will be more securely retained within the vagina. Advantageously, the device may be selectively positioned within the vagina so that each of the legs may respectively contact the left vaginal wall and the right vaginal wall or the anterior vaginal wall and the posterior vaginal wall.
Because of the C-shaped configuration, the device may be inserted so that in use, the device has an upwardly convex shape with the legs extending downward. In this configuration, the member is provided on the distal end of at least one leg and typically provided on the distal end of each leg. In this regard, the member may include a first removal member provided on the distal portion of the first leg and a second removal member provided on the distal portion of the second leg. Each of the first and second removal members may include a string.
To aid the insertion of the device, the member may further include an insertion member that may be separate from the removal member or may be formed as part of the removal member. The insertion member may take any of several forms such that a first insertion member is provided on the distal portion of the first leg and a second insertion member is provided on the distal portion of the second leg.
Alternatively, the device may be inserted so that in use, the device has a downwardly concave shape with the legs extending upward. In this embodiment, the member is provided on the outer surface of the base portion of the device. The member may be integrally formed with the device and shaped to provide a surface that can be gripped for insertion and removal of the device.
Put another way, the device of the present invention is an intra-vaginal device that has a first portion to engage either an anterior vaginal wall or a left vaginal wall and a second portion to engage either a posterior vaginal wall or a right vaginal wall, respectively. The device has a generally arcuate configuration and is formed of a resilient material so that in use it may be resiliently deformed and therefore bias the first and second portions into contact with the anterior and posterior (or left and right) vaginal walls, respectively to retain the device in position within the vagina. The device also has a member connected to the base wherein the member is selected from the group consisting of an insertion member, a removal member, and a combination of both. The member may be integrally formed as part of the device.
The present invention also includes a method of alleviating female urinary incontinence by providing a female urinary incontinence device as described above and in the specification, selectively inserting the device into a woman""s vagina while compressing the legs of the device toward each other, and allowing the legs of the device to expand within the vaginal canal so that each leg of the device respectively contacts the left vaginal wall and the right vaginal wall or the anterior vaginal wall and the posterior vaginal wall.
Advantageously, the device and method of present invention provides for control of female urinary incontinence by use of a device that does not create undue friction or distension of the mucosal tissue and yet allows for normal discharge of vaginal secretions.